Z-0162-2018 Class II Terminated
FDA device recall Z-0162-2018 was initiated by Medline Industries Inc on October 23, 2017 and is designated Class II. Reason for recall: Possible open seal on top portion of the package. Could cause breach of sterility. The recall status is terminated (terminated April 6, 2021). Affected quantity: 8,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- October 23, 2017
- Termination Date
- April 6, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,000 units
Product Description
Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
Reason for Recall
Possible open seal on top portion of the package. Could cause breach of sterility.
Distribution Pattern
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.
Code Information
Model No. MSG1285, Lot No. 701893369485